Treatment of Apathy in Alzheimer's Disease With Modafinil
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ClinicalTrials.gov Identifier: NCT01172145 |
Recruitment Status :
Completed
First Posted : July 29, 2010
Results First Posted : March 4, 2011
Last Update Posted : March 4, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Apathy Alzheimer's Disease | Drug: Modafinil Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Apathy in Alzheimer's Disease With Modafinil |
Study Start Date : | July 2005 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Cholinesterase inhibitor only |
Drug: Placebo
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks |
Experimental: Cholinesterase Plus Modafinil |
Drug: Modafinil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Other Name: Provigil |
- Apathy [ Time Frame: at baseline ]The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
- Apathy [ Time Frame: after 8 weeks of treatment ]The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
- Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: at baseline ]Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
- The Direct Assessment of Functional Status Scale [ Time Frame: at baseline ]A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
- Zarit Burden Inventory [ Time Frame: at baseline ]Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
- Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: after 8 weeks of treatment ]Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
- The Direct Assessment of Functional Status Scale [ Time Frame: after 8 weeks of treatment ]A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
- Zarit Burden Inventory [ Time Frame: after 8 weeks of treatment ]Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.

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Ages Eligible for Study: | 65 Years to 95 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- diagnosis of mild to moderate stage Probable Alzheimer's disease
- on a stable dose of a cholinesterase inhibitor medication for at least 30 days
- clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale
Exclusion Criteria:
- diagnosis of Major Depression
- focal brain lesion on neuroimaging
- history of significant substance abuse
- history of significant head trauma with loss if consciousness >10 minutes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172145
United States, Rhode Island | |
Butler Hospital | |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Laura L Frakey, Ph.D. | Memorial Hospital of Rhode Island |
Responsible Party: | Laura L. Frakey, Brown University |
ClinicalTrials.gov Identifier: | NCT01172145 |
Other Study ID Numbers: |
1F32MH075583-01 ( U.S. NIH Grant/Contract ) 1F32MH075583-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 29, 2010 Key Record Dates |
Results First Posted: | March 4, 2011 |
Last Update Posted: | March 4, 2011 |
Last Verified: | September 2010 |
apathy Alzheimer's disease activities of daily living performance caregiver burden |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Wakefulness-Promoting Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |